Z-1735-2013Class II

Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth...

Name: Z-1735-2013 Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth...
Creator: Paa Laboratories Inc
Published: 2013-04-12
License: https://open.fda.gov/license/

Paa Laboratories Inc / initiated 2013-04-12 / Terminated / root cause: labeling and UDI

FDA source

Paa Laboratories Inc began a recall of Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems on 2013-04-12. FDA classified it as Class II and gives the reason as "Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pure Fetal Bovine Serum (FBS). These products may contain added adult Bovine Serum Albumin (BSA)of United States origin...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1735-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-12
Posted: 2013-07-15
Terminated: 2015-09-14
Recalling firm: Paa Laboratories Inc
Product: Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
Product code: KIS Sera, Animal And Human
Reason for recall: Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pure Fetal Bovine Serum (FBS). These products may contain added adult Bovine Serum Albumin (BSA)of United States origin, water, and/or cell growth promoting additives. All other FBS products, as listed below, including FBS Gold and FBS Standard, described as specialty sera', may contain adult BSA of Un
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: GE Healthcare notified customers via USPS on April 12, 2013 and April 14, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers being contacted by phone as well. Customers were asked to contact their local customer service representative if the product does not meet their needs. Customers were instructed to call (732) 457-8455 or 301-660-0256. For questions regarding this recall call 609-514-6888.
Quantity in commerce: approximately 280,000 liters
Distribution: Worldwide Distribution - USA (nationwide), Novia Scotia, and Canada
Product codes and lots: 510 k exempt No Medical Device Listing number All batches produced within the last 5 years (143 batches)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1735-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1735-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-15

Product code KIS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)